- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02656095
Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment
This study plans to learn more about measuring Lipoprotein lipase (LPL) activity in humans. LPL is an enzyme in the breakdown of certain types of fats into smaller parts. Lipoprotein lipase deficiency (LPLD) is a very rare genetic disorder in which lipoprotein enzyme is no longer functional. This can cause conditions known as high triglycerides in the blood and inflammation of the pancreas.
Investigational medications to treat LPLD are currently being developed. In order to see if these medications are effective, it is necessary to be able to accurately measure LPL activity in humans.
LPL activity has been successfully measured in animal models after giving heparin. Heparin is a blood thinner which is approved by the FDA. It is originally used to prevent blood clots. This study will administer heparin to healthy adults through intravenous infusion (IV). Blood samples will be collected before and after the infusion to test LDL levels.
The purpose of this study is to develop a cheap, more reliable standard for assessment of LPLD in patients
Study Overview
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
1. male and females between ages of 20-39
Exclusion Criteria:
- Past history of LPL deficiency
- Hypercholesterolemia (Cholesterol >200, LDL >160, HDL <35) hypertriglyceridemia (TG>150), any familial lipid disorder
- Diabetes mellitus (type 1 or 2)
- Uncontrolled hypertension SBP>140, DBP>90
- History of hemorrhagic stroke
- Current pregnancy
- History of major surgery, invasive procedure or trauma within the last 30 days, or planned major surgery within 30 days after participating in the study
- Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 30 days prior to screening
- History of allergy to heparin
- History of heparin-induced thrombocytopenia
- Current smoking
- Active ulcerative or angiodysplastic GI diseases
- Thrombocytopenia or platelet disorders (Platelet count <100,000/UL)
Major health issues which may affect the safety of study subject, including but not limited to:
- History of chronic kidney disease (eGFR<60)
- Long term use of medications which alter lipid metabolism
- History of hepatic disease (ALT or AST more than 2 times the upper limit of normal)
- History of clotting disorders, any type of coagulation factor deficiency, or thrombocytopenia
- Chronic use of ASA, anticoagulants, platelet inhibitors
- Use of NSAIDS for more than 2 weeks prior to screening
- Anemia (hemoglobin <13 g/dL)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Lipoprotein lipase levels
Time Frame: 10-15 minutes post-heparin adminstration
|
Blood will be drawn after IV heparin administration and run through assay to determine lipoprotein lipase levels.
|
10-15 minutes post-heparin adminstration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Eckel, MD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism, Inborn Errors
- Hyperlipoproteinemias
- Hyperlipoproteinemia Type I
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin
Other Study ID Numbers
- 15-1412
- UL1TR001082 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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